ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

HFinCH

Study hypothesis

The purpose of this study is to explore the experiences of diagnosis and treatment of heart failure (HF) for people who are resident in care, and to ascertain the prevalence of HF in a very high risk population, with a view to providing more effective care. The study will provide vital information about the accuracy, feasibility and acceptability of the diagnostic tests used. The study will evaluate the best way of delivering improved healthcare by comparing usual NHS care with a specialist-led service. The study will allow people with heart failure to help inform the development of new and important NHS services that meet patients' needs.

Patient information sheet

Condition

Intervention

Domiciliary Heart Failure Team Care (HFTC) versus Routine Care (RC). RC will consist of test results being communicated to residents and their GPs and/or HF nurse specialists. In addition to routine care, HFTC will involve residents being visited within the home by clinical members of the research team on a number of occasions to have their findings assessed, receive educational advice, discuss options and have their medication reviewed.

Secondary outcome measures

Diagnostic phase:1. Prevalence of HF analyzed as a proportion2. Proportions where HF has been missed or incorrectly identified3. Test accuracy (sensitivity, specificity) of NT-Pro BNP, ECG and clinical signs and symptoms for the diagnosis of HF4. Positive and negative predictive values 5. Acceptability to patients6. Symptom profiles and quality-of-life (EuroQoL measures)

Trial phase:1. The proportion of patients dying or being hospitalised for HF (one year)2. The proportion of patients dying or being hospitalised for any cardiovascular or cerebrovascular event (one year)3. The net costs of providing the specialist service and change in prescribing (6 months)4. Changes in use of other CV drugs (6 months)5. Changes in functional capacity and quality of life (3 months)

Overall trial start date

01/04/2009

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Residential/care home managers2. Residents of residential/care homes in Stockton-on-Tees who are aged 65 years or over, either sex3. Health care professionals, including a representative sample of GPs, HF nurses, and care home staff, involved in care provision will be invited to participate in interviews

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 500; UK sample size: 500

Participant exclusion criteria

Residents with terminal disease

Recruitment start date

01/04/2009

Recruitment end date

01/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Medicine and Health
Durham
DH1 3HP
United Kingdom

Sponsor information

Organisation

University of Durham (UK)

Sponsor details

School of Medicine and Health Queens Campus Wolfson Research Institute University Boulevard Stockton-on-Tees TS17 6BH United Kingdom